Safety and Efficacy of Cariprazine in Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01104779
• Date of registration: 14/04/2010
• Prospective Registration: Yes
• Primary sponsor: Forest Laboratories
• Public title: Safety and Efficacy of Cariprazine in Schizophrenia
• Scientific title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
• Date of first enrolment: April 27, 2010
• Target sample size: 446
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01104779
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Colombia, India, South Africa, United States

Contacts

• Name: Raffaele Migliore, MA
• Affiliation: Forest Laboratories

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have provided informed consent prior to any study specific procedures

- Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type,
disorganized type, catatonic type or undifferentiated type), as confirmed by the
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition (SCID)

- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS)
total score = 80 and = 120

- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1

- Patients with normal physical examination, laboratory, vital signs,and/ or
electrocardiogram (ECG)

Exclusion Criteria:

- Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform
disorder, other psychotic disorders other than schizophrenia, or bipolar I or II
disorder

- Patients in their first episode of psychosis

- Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during
the study

- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and
other cognitive disorders

- Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR
axis II disorder of sufficient severity to interfere with participation in this study

- Substance abuse or dependence within the prior 3 months



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Cariprazine

Drug: Placebo

Primary Outcome(s)

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [Time Frame: Baseline to Week 6]

Secondary Outcome(s)

Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S) [Time Frame: Baseline to Week 6]

Secondary ID(s)

RGH-MD-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Gedeon Richter Ltd.

Results

• Results available: Yes
• Date Posted: 14/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01104779